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Knee Replacement System-Femoral - India CDSCO Medical Device Registration

Knee Replacement System-Femoral is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000556_ea8ef357146176f952d311ecdb7ac72b_5f5660686c327a455b01a7725c7672e1. This device is marketed under the brand name Sigma PS. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class D
Knee Replacement System-Femoral
UID: IMP/MD/2020/000556_ea8ef357146176f952d311ecdb7ac72b_5f5660686c327a455b01a7725c7672e1

Brand Name

Sigma PS

Device Class

Class D

Approving Authority

CDSCO

Product Information

The DePuy SIGMA High Performance Partial Knee System is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. INDICATION The SIGMA High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals withosteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history ofgout or pseudogout. All components are intended for CEMENTED USE ONLY. Updation of IFU including Indications and Contraindications

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